Oxus Cited for CAPA Failures

March 17, 2020

Failure to establish corrective and preventive actions procedures and systems for receiving, reviewing and evaluating complaints landed devicemaker Oxus a 483 following the FDA’s inspection of its Michigan facility.

The firm, which makes portable oxygen concentrators, created CAPAs for several malfunctions following an external quality audit, but it failed to follow up for at least three, the FDA said.

In addition, complaints were not handled in a timely manner and the FDA investigator observed that eight of 11 complaints were not closed even though they had been open for more than a year.